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Transmucosal drug delivery devices for use in chronic pain relief

a technology of drug delivery device and chronic pain, which is applied in the direction of pharmaceutical active ingredients, medical preparations, organic active ingredients, etc., can solve the problems of marked alteration in behavior, excessive use of medication and medical services, and restriction in daily activities, so as to efficiently treat chronic pain

Active Publication Date: 2017-02-09
BIODELIVERY SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0012]The present teachings provide methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a mucoadhesive bioerodable drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects, for example, less than 15% (preferably less than 10%, more preferably less than 5%) patients experience constipation.
[0014]In one embodiment, the buprenorphine delivery device comprises a bioerodable mucoadhesive layer comprising a therapeutically effective amount of buprenorphine disposed in a buffered polymeric diffusion environment, wherein the polymeric diffusion environment is a buffered environment having a pH of between about 4 and about 6. In another embodiment, the buprenorphine delivery device further comprises a bather layer comprising a polymeric barrier environment disposed adjacent to the mucoadhesive layer to provide a unidirectional gradient upon application to a mucosal surface for the rapid and efficient delivery of buprenorphine, wherein the unidirectional gradient delivers buprenorphine across the buffered polymeric diffusion environment upon application to the mucosal surface. In still another embodiment, the device comprises a mucoadhesive layer comprising an effective amount of buprenorphine buffered to a pH of between about 4.0 and about 6.0, and a backing layer buffered to a pH between about 4.0 and about 4.8.

Problems solved by technology

Chronic pain can cause a marked alteration in behavior with depression and anxiety, restriction in daily activities and excessive use of medication and medical services in an afflicted individual.
The treatment of chronic pain is difficult, often inadequate and associated with high economic and psychological cost.
Buprenorphine has a low oral bioavailability due to very high first-pass metabolism.

Method used

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  • Transmucosal drug delivery devices for use in chronic pain relief
  • Transmucosal drug delivery devices for use in chronic pain relief
  • Transmucosal drug delivery devices for use in chronic pain relief

Examples

Experimental program
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example 1

Preparation of the Devices of the Invention

[0064]Transmucosal devices are configured in the form of a disc, rectangular in shape with round corners, yellow on one or both sides of the cheek). Buprenorphine is present in the mucoadhesive layer, and this side is to be placed in contact with the buccal mucosa (inside the cheek). The drug is delivered into and across the mucosa as the disc erodes in the mouth. The non-adhesive, backing layer controls the rate erosion of the disc, and minimizes the amount of buprenorphine dissolved in saliva and ultimately swallowed, a pathway of lower absorption due first pass metabolism. The mucoadhesive polymeric diffusion layer and the backing layer are bonded together and do not delaminate during or after application.

[0065]The mucoadhesive layer for the transmucosal devices of the present invention comprising the desired dosage of buprenorphine is prepared by mixing purified water, propylene glycol (about 4.6% total formulation, by dry weight), sodi...

example 2

Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy of BEMA Buprenorphine in Subjects with Moderate to Severe Chronic Low Back Pain

[0068]A 12-week, placebo-controlled, double-blind randomized withdrawal study was conducted to evaluate the efficacy and safety of buprenorphine delivered twice daily via transmucosal drug delivery device with enhanced uptake (BEMA buprenorphine) in subjects with moderate to severe chronic low back pain. The study was also designed to define the range of BEMA Buprenorphine doses effective for management of moderate to severe chronic lower back pain.

i. Study Design

[0069]The study consisted of an open-label dose titration period lasting up to 4 weeks, followed by a randomized, double-blind, placebo-controlled treatment period of 12 weeks. The subjects continued on their current pain therapy during the initial screening period (days −14 to −1) and until 12 to 24 hours prior to Day 0 / 1 of the open-label dose titration period. Predose assessments ...

example 3

Pharmacokinetic Profiles for BEMA Buprenorphine

[0083]Pharmacokinetic parameters for the BEMA Buprenorphine doses used in the treatment of chronic pain were determined in a separate, multiple dose study. BEMA Buprenorphine contained buprenorphine doses of 2×A μg, and 4×A μg. Each dose was administered twice daily for 3 days with serial blood samples collected. Selected pharmacokinetic parameters are shown in the Table 16 below.

TABLE 16Selected Pharmacokinetic Parameters for BEMA BuprenorphineBuccal Films comprising 1xA μg, 2xA μg, 3xA μg and4xA μg buprenorphinePharmacokinetic Parameters(Mean values)1xA μg2xA μg3xA μg4xA μgTmax (hr)2.902.612.002.20Cmax (ng / mL)0.07660.1560.2160.364Cmin (ng / mL)0.01570.03710.05580.0862Cavg (ng / mL)0.04090.08050.1130.195AUC0-τ (hr*ng / mL)0.49030.96581.3582.343AUClast (hr*ng / mL)0.40850.79021.1115.033Tmax refers to the time to reach the steady-state Cmax of plasma buprenorphine concentration.Cmax refers to the maximum concentration in plasma in steady-state.C...

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Abstract

Provided herein are methods for treating chronic pain by administering low doses of buprenorphine twice daily (or once daily) via a transmucosal drug delivery device. The methods and devices efficiently treat chronic pain without significant side effects.

Description

RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application No. 61 / 578,755, filed Dec. 21, 2011. The entire contents of this application are incorporated herein by reference.[0002]This application is related to U.S. patent application Ser. No. 08 / 734,519, filed on Oct. 18, 1996, now U.S. Pat. No. 5,800,832, issued Sep. 1, 1998; U.S. patent application Ser. No. 09 / 144,827, filed on Sep. 1, 1998, now U.S. Pat. No. 6,159,498, issued on Dec. 12, 2000; U.S. patent application Ser. No. 11 / 069,089, filed on Mar. 1, 2005, now U.S. Pat. No. 7,579,019, issued on Aug. 25, 2009; U.S. patent application Ser. No. 11 / 639,408, filed on Dec. 13, 2006; U.S. patent application Ser. No. 11 / 817,915, filed on Sep. 6, 2007; U.S. patent application Ser. No. 13 / 834,306, filed on Jul. 15, 2011, now U.S. Pat. No. 8,147,866, issued on Apr. 3, 2012; U.S. patent application Ser. No. 13 / 590,094, filed on Aug. 20, 2012, the entire contents of which are incorporated herein by referenc...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00
CPCA61K9/00A61K9/006A61K31/485
Inventor FINN, ANDREWVASISHT, NIRAJ
Owner BIODELIVERY SCI
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